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On July 2 2006 I had what I thought was a bad run of atonic seizures. My parents just happened to stop by that Sunday morning and realized something was terribly wrong with me. They called my neurologist and EMS.

My last memory of that morning was being inside of the ambulance the next thing I knew I was in the ICU.

The Vagus Nerve Stimulator was stopping my heart (asystole) every 3 minutes during the 30 second stimulation cycles. If my parents hadn't happened to stop by that day I would have died and my death would have probably just been written off as a fatal seizure or SUDEP. No one would have ever suspected it was the vns that killed me.

Once the ER doctor and my neurologist realized that the problem was cardiac and not seizures my neurologist had to ran to his office (the next building) to retrieve the equipment to deactivate the device. When the vns was turned off I regained a normal heart beat and have had no cardiac issues in the 6 years since.

The device was implanted in 2000 and I had absolutely no problems until it nearly killed me in 2006.

As of 6/29/2012 there are 1184 "reported" deaths and over 17,000 "reported" adverse events for approx. 70,000 registered vagus nerve simulators. Something is REALLY wrong with that picture.

DR. PIANTADOSI: Could I just ask the FDA very directly--I'm not confused about what the company thinks, and I really am not interested in the nuances of how SUDEP is defined. Is the FDA satisfied that this device is not associated with an elevated risk of death, all-cause mortality, whatever you want?

DR. COSTELLO:............So, to answer your question, I don't believe it has been shown that the high death rate is directly related to the device. However, we only have 2,000 patient years of experience and a limited number of patients...............I cannot say that I believe that there is an increased risk right now, but I would not want to rule it out either. I think that would require a longer-term study.

24 Replies |Watch This Discussion | Report This| Share this:Vagus Nerve StimulatorOn July 2 2006 I had what I thought was a bad run of atonic seizures. My parents just happened to stop by that Sunday morning and realized something was terribly wrong with me. They called my neurologist and EMS.

My last memory of that morning was being inside of the ambulance the next thing I knew I was in the ICU.

The Vagus Nerve Stimulator was stopping my heart (asystole) every 3 minutes during the 30 second stimulation cycles. If my parents hadn't happened to stop by that day I would have died and my death would have probably just been written off as a fatal seizure or SUDEP. No one would have ever suspected it was the vns that killed me.

Once the ER doctor and my neurologist realized that the problem was cardiac and not seizures my neurologist had to ran to his office (the next building) to retrieve the equipment to deactivate the device. When the vns was turned off I regained a normal heart beat and have had no cardiac issues in the 6 years since.

The device was implanted in 2000 and I had absolutely no problems until it nearly killed me in 2006.

As of 6/29/2012 there are 1184 "reported" deaths and over 17,000 "reported" adverse events for approx. 70,000 registered vagus nerve simulators. Something is REALLY wrong with that picture.

DR. PIANTADOSI: Could I just ask the FDA very directly--I'm not confused about what the company thinks, and I really am not interested in the nuances of how SUDEP is defined. Is the FDA satisfied that this device is not associated with an elevated risk of death, all-cause mortality, whatever you want?

DR. COSTELLO:............So, to answer your question, I don't believe it has been shown that the high death rate is directly related to the device. However, we only have 2,000 patient years of experience and a limited number of patients...............I cannot say that I believe that there is an increased risk right now, but I would not want to rule it out either. I think that would require a longer-term study.

Very Interesting Facts. A Very Good Warning to those w/ the VNS. And even though hula-dancer is Grateful for hers, I Hope she remembers this article & Never takes the VNS or Possible Side Effects Lightly or for Granted. The Stats are Scary to say the least.

Nancy, Dennis did Not have a SUDEP episode. He Mite have been diagnosed as SUDEP IF his DR hadn't figured out the problem. He also had his in Longer than you. I wish you continued success on the VNS, but, Stay Aware & Educated!

Dennis, what med/treatment are you on now & does it work for you?

Love Candi

Thanks for your Reply!

Report This| Share this:Vagus Nerve StimulatorVery Interesting Facts. A Very Good Warning to those w/ the VNS. And even though hula-dancer is Grateful for hers, I Hope she remembers this article & Never takes the VNS or Possible Side Effects Lightly or for Granted. The Stats are Scary to say the least.

Nancy, Dennis did Not have a SUDEP episode. He Mite have been diagnosed as SUDEP IF his DR hadn't figured out the problem. He also had his in Longer than you. I wish you continued success on the VNS, but, Stay Aware & Educated!

to me whatever happens to some other with the VNS is all different from o thers. So he had a bad reaction to it i did not.

Everryone is different and I am not going to believe this s tuf f.

My doc is not believeing it ei ther and the rep back iin PHX who stays in touch with me said not trus that they are and never can be defective. HE knows what he is talking about.

please quit telling me to wat ch it, becuase I have had not probelms with it and both my mom and my hsuband area grateful I have it or I would not be alive to talkabout it, I would be dead from NOT having it.

I am pretty sure that if something went wrong with my body or in this case INSIDE my body I would be the first ot know about it. So far NOTHING!

All you are doing is scaring me and that causes stress so then I am having more szs. NOT something I enjoy going through.

hula_dancer

Thanks for your Reply!

Report This| Share this:Vagus Nerve Stimulatorto me whatever happens to some other with the VNS is all different from o thers. So he had a bad reaction to it i did not.

Everryone is different and I am not going to believe this s tuf f.

My doc is not believeing it ei ther and the rep back iin PHX who stays in touch with me said not trus that they are and never can be defective. HE knows what he is talking about.

please quit telling me to wat ch it, becuase I have had not probelms with it and both my mom and my hsuband area grateful I have it or I would not be alive to talkabout it, I would be dead from NOT having it.

I am pretty sure that if something went wrong with my body or in this case INSIDE my body I would be the first ot know about it. So far NOTHING!

All you are doing is scaring me and that causes stress so then I am having more szs. NOT something I enjoy going through.

You say you are a Rep for VNS! So, you only tell others' what works for You? I should Hope Not! People Need to Know Both Sides of the Story on any Treatment! And if you are an Honest to Goodness Rep it is up to You to Keep them Informed! Of the Good & Bad!

Your doc Don't believe it? Who is he to Question an Article? Written by an Infamous Source: Readers Digest! Not to mention all the Research Links Posted w/ this. Our site isn't the Only one who has Posted this News. Other Sites & Medical Journals are saying the Same!

Rep in Phoenix says Not to Trust this Info? He is just as much a Fool as Your DR. !

I Apologize if this upsets You! You have & always will be My Friend! I am Truly Grateful, as your family is, that the VNS is working for you. I'm Not Trying to Scare You or Stress you Out!! I just want you to stay Informed! It's Good that You personally have no issues w/ the VNS. I am Sure there are others' who are doing just as well. Just Stay INFORMED/Educated! And keep your mind Open! A good Rep does that & More!

You say you are a Rep for VNS! So, you only tell others' what works for You? I should Hope Not! People Need to Know Both Sides of the Story on any Treatment! And if you are an Honest to Goodness Rep it is up to You to Keep them Informed! Of the Good & Bad!

Your doc Don't believe it? Who is he to Question an Article? Written by an Infamous Source: Readers Digest! Not to mention all the Research Links Posted w/ this. Our site isn't the Only one who has Posted this News. Other Sites & Medical Journals are saying the Same!

Rep in Phoenix says Not to Trust this Info? He is just as much a Fool as Your DR. !

I Apologize if this upsets You! You have & always will be My Friend! I am Truly Grateful, as your family is, that the VNS is working for you. I'm Not Trying to Scare You or Stress you Out!! I just want you to stay Informed! It's Good that You personally have no issues w/ the VNS. I am Sure there are others' who are doing just as well. Just Stay INFORMED/Educated! And keep your mind Open! A good Rep does that & More!

Hi Candi, Right now I'm taking Felbamate, Lyrica, Sertraline & Clonazepam. The Felbamate is causing some problems and it also has a black box warning so I plan to get off of it soon. My seizures have never been completely controlled. I average 6 to 8 complex partials a month and a few tonic clonics a year. Without meds I'll have over 300 a year.

A little more info for Hula

1997 FDA CDRH Neurological Devices Panel

DR. COSTELLO: Good afternoon, Dr. Wilkinson and members of the panel. This afternoon, I will be discussing issues regarding the safety and effectiveness of the vagus nerve stimulation device......................One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.................This slide shows each of the studies and the percent seizure increase. As you can see, in each of the studies, there were patients who had greater than a 100 percent increase. In the E05 study, the range went up to a 234 percent increase, while in the E04 study, it went even higher, to a 680 percent maximum range.

DR. PIANTADOSI: Yes; well, one of the things that's concerning me is that the endpoint being measured in all of these studies is, in some sense, a surrogate, counting the number of seizures. I realize that to the patient and to others, it is a very important endpoint, but it may not be as definitive as some other things that we could measure. And there are numerous examples in the methodologic literature about the weaknesses of accepting clinical trial data based on surrogate outcomes, and I would point to, as a recent and a very dramatic example, the cardiac arrhythmia suppression trial, in which the study was designed and the endpoint was selected on the basis of looking at arrhythmias and suppressing them with a drug. And the studies originally seemed to show that the drug was effective in suppressing arrhythmias. The problem was that it was so good in suppressing arrhythmias that it was killing people, and the mechanism was not understood until much later and wasn't even believed until the results of the randomized trial. So, I am very nervous when I see high mortality rates associated with a supposed benefit, even though we don't have a way biologically right now to connect the two. So, that is why I have harped on this this morning and why I am still very nervous with this high death rate. What's your sense of that? I mean, I'm struggling to get some reassurance that my concerns are not well-founded.

FDA's failure to enforce it's stated requirement of the manufacturer that the company track patients deaths and because the manufacturer has acknowledged that it did not track deaths in any of the five studies it alleges shows its safety record.The FDA should live up to its commitment to oversee the safety of this device and demand new studies of the manufacturer that actually track deaths.

My personal opinion is that the VNS is nothing more than a placebo. Cyberonics touts a success rate of 33%. The success rate of the placebo effect can run as high as 35%.

Thanks for your Reply!

Report This| Share this:Vagus Nerve StimulatorHi Candi, Right now I'm taking Felbamate, Lyrica, Sertraline & Clonazepam. The Felbamate is causing some problems and it also has a black box warning so I plan to get off of it soon. My seizures have never been completely controlled. I average 6 to 8 complex partials a month and a few tonic clonics a year. Without meds I'll have over 300 a year.

A little more info for Hula

1997 FDA CDRH Neurological Devices Panel

DR. COSTELLO: Good afternoon, Dr. Wilkinson and members of the panel. This afternoon, I will be discussing issues regarding the safety and effectiveness of the vagus nerve stimulation device......................One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.................This slide shows each of the studies and the percent seizure increase. As you can see, in each of the studies, there were patients who had greater than a 100 percent increase. In the E05 study, the range went up to a 234 percent increase, while in the E04 study, it went even higher, to a 680 percent maximum range.

DR. PIANTADOSI: Yes; well, one of the things that's concerning me is that the endpoint being measured in all of these studies is, in some sense, a surrogate, counting the number of seizures. I realize that to the patient and to others, it is a very important endpoint, but it may not be as definitive as some other things that we could measure. And there are numerous examples in the methodologic literature about the weaknesses of accepting clinical trial data based on surrogate outcomes, and I would point to, as a recent and a very dramatic example, the cardiac arrhythmia suppression trial, in which the study was designed and the endpoint was selected on the basis of looking at arrhythmias and suppressing them with a drug. And the studies originally seemed to show that the drug was effective in suppressing arrhythmias. The problem was that it was so good in suppressing arrhythmias that it was killing people, and the mechanism was not understood until much later and wasn't even believed until the results of the randomized trial. So, I am very nervous when I see high mortality rates associated with a supposed benefit, even though we don't have a way biologically right now to connect the two. So, that is why I have harped on this this morning and why I am still very nervous with this high death rate. What's your sense of that? I mean, I'm struggling to get some reassurance that my concerns are not well-founded.

FDA's failure to enforce it's stated requirement of the manufacturer that the company track patients deaths and because the manufacturer has acknowledged that it did not track deaths in any of the five studies it alleges shows its safety record.The FDA should live up to its commitment to oversee the safety of this device and demand new studies of the manufacturer that actually track deaths.

I agree, you Should have 1 or more of those eliminated or substituted. It took me 10 yrs of 'trial & error'. One thing I Still Regret: None of my DRS Ever told me about Diets! The Info & Success for Some is Amazing! My Sister is One of the Successes.

I have been on 180mg of Phenobarbital for over 24 yrs. Been controlled for 23 yrs. If I had a Good Neuro in this area, I would like to at Least Try 1 of the Diets. I Am Implementing Juicies (Fruit/veg/yogurt/coconut milk blend) into my regimen. Hopefully, That will help w/ the Simple Complexes I have periodically experienced w/in the past 2-3 yrs.

BTW: Welcome to Epland. Know We Care! Thank You for sharing your story & Info. We Need More People Like You! Stay Strong & Keep in Touch!

Hugs! Love Candi

Thanks for your Reply!

Report This| Share this:Vagus Nerve StimulatorI agree, you Should have 1 or more of those eliminated or substituted. It took me 10 yrs of 'trial & error'. One thing I Still Regret: None of my DRS Ever told me about Diets! The Info & Success for Some is Amazing! My Sister is One of the Successes.

I have been on 180mg of Phenobarbital for over 24 yrs. Been controlled for 23 yrs. If I had a Good Neuro in this area, I would like to at Least Try 1 of the Diets. I Am Implementing Juicies (Fruit/veg/yogurt/coconut milk blend) into my regimen. Hopefully, That will help w/ the Simple Complexes I have periodically experienced w/in the past 2-3 yrs.

BTW: Welcome to Epland. Know We Care! Thank You for sharing your story & Info. We Need More People Like You! Stay Strong & Keep in Touch!

Your story and information caught my attention right away. The first time I heard about this was in the reader's digest story. Yes the facts are correct, but this does not happen to everyone.

Medtronics had some very defects with the equipment which first showed up with pacemakers and now the VNS. There are many people who have the VNS implanted and are doing much better with reduced seizures, but their VNS is monitored carefully and frequently.

You are correct about the possible defects that could and have happened, but this is a decision for the patient and doctor to make about having the VNS implanted.

If medications were not controlling your seizures and you were not a candidate for brain surgery, then the VNS may have been your last resort. I do not blame you for bringing the information out to society, but what about the people who are doing fine and have had no problems?

The VNS like medications has side effects, which I just learned about this year from a friend in an Epilepsy Support group. I know two people who had their VNS replaced and several who had their adjusted to make sure that that the patient was safe.

Have you tried alternative options for seizure control? Over the course of my journey with seizures I tried acupuncture, chiropractive care, medications and then it was choice between the VNS or brain surgery. If brain surgery could not have been done I would have gone with the VNS just to see what the outcome would be.

I personally know two other people that would not be living today if they did not have the VNS so there are always two sides to every story.

We need to keep the facts out in the open, but also show the good side of treatment for seizures which some have and some do not.

best wishes.

Thanks for your Reply!

Report This| Share this:Vagus Nerve StimulatorYour story and information caught my attention right away. The first time I heard about this was in the reader's digest story. Yes the facts are correct, but this does not happen to everyone.

Medtronics had some very defects with the equipment which first showed up with pacemakers and now the VNS. There are many people who have the VNS implanted and are doing much better with reduced seizures, but their VNS is monitored carefully and frequently.

You are correct about the possible defects that could and have happened, but this is a decision for the patient and doctor to make about having the VNS implanted.

If medications were not controlling your seizures and you were not a candidate for brain surgery, then the VNS may have been your last resort. I do not blame you for bringing the information out to society, but what about the people who are doing fine and have had no problems?

The VNS like medications has side effects, which I just learned about this year from a friend in an Epilepsy Support group. I know two people who had their VNS replaced and several who had their adjusted to make sure that that the patient was safe.

Have you tried alternative options for seizure control? Over the course of my journey with seizures I tried acupuncture, chiropractive care, medications and then it was choice between the VNS or brain surgery. If brain surgery could not have been done I would have gone with the VNS just to see what the outcome would be.

I personally know two other people that would not be living today if they did not have the VNS so there are always two sides to every story.

We need to keep the facts out in the open, but also show the good side of treatment for seizures which some have and some do not.

Thank You Dana. Your '2 cents' was Much Appreciated by Me.I Still go by the adage 'What works for one, may not work for another.' But, Staying Informed/Up-to-Date, Is Important!

After 20 yrs on Phenobarbital, I never realized it was responsible for my 'mood swings'. But, thanks to new research & my constant need for New Info, I now Know, this is sooo True for me. Yet, others have no problem. It's the Oldest med out there. Yet, it took 90??? yrs to figure it out. Researchers & Us, Learn something New everyday.

Even brain surgery has New Info. And Those Findings/Stats may or may not Increase w/ Time. And may or may not affect certain Individuals. But, it is still Good to Know the Latest Findings. To Stay Aware of any & all possibilities.

Report This| Share this:Vagus Nerve StimulatorThank You Dana. Your '2 cents' was Much Appreciated by Me.I Still go by the adage 'What works for one, may not work for another.' But, Staying Informed/Up-to-Date, Is Important!

After 20 yrs on Phenobarbital, I never realized it was responsible for my 'mood swings'. But, thanks to new research & my constant need for New Info, I now Know, this is sooo True for me. Yet, others have no problem. It's the Oldest med out there. Yet, it took 90??? yrs to figure it out. Researchers & Us, Learn something New everyday.

Even brain surgery has New Info. And Those Findings/Stats may or may not Increase w/ Time. And may or may not affect certain Individuals. But, it is still Good to Know the Latest Findings. To Stay Aware of any & all possibilities.

I want to apologize to everyone who posted on this thread. Iam sorry I fought will all of yyou and nowfeel badl=.

Dennis you had it implanted a year before it was relssaased by the FDA which why you may have had some problems with it. IS just wasn't re ady and things probably still had to be downe with it to make sure it was safe for people.

Dennis you had it implanted a year before it was relssaased by the FDA which why you may have had some problems with it. IS just wasn't re ady and things probably still had to be downe with it to make sure it was safe for people.

Just to clarify the VNS approval. It was officially approved by the FDA in 1997. Dennis could not have received the implant if it was not approved yet. The VNS was available in 2001 when my doctors were considering the option for myself.

At the time it was approved it was still new and doctors had to learn carefully how to program and reprogram the device for each patient differently and it will always be a learning experience because it is a medical device.

The main problem came from the Medtronic's defect which affected VNS and pacemakers so let's keep our information correct on this sight. I am not downgrading just giving a little advice.

Dennis has some very good legitimate information with proof of problems that occurred that is what he was trying to inform anyone reading this sight, but there are always good and bad outcomes when it comes to the medical technology.

Thanks for your Reply!

Report This| Share this:Vagus Nerve StimulatorJust to clarify the VNS approval. It was officially approved by the FDA in 1997. Dennis could not have received the implant if it was not approved yet. The VNS was available in 2001 when my doctors were considering the option for myself.

At the time it was approved it was still new and doctors had to learn carefully how to program and reprogram the device for each patient differently and it will always be a learning experience because it is a medical device.

The main problem came from the Medtronic's defect which affected VNS and pacemakers so let's keep our information correct on this sight. I am not downgrading just giving a little advice.

Dennis has some very good legitimate information with proof of problems that occurred that is what he was trying to inform anyone reading this sight, but there are always good and bad outcomes when it comes to the medical technology.

Thank You Dana. Yes, Dennis Said his was implanted in 2000 & he even gave 2012 Stats. So, he Has done his Homework as well as shared his experience. I agree: There is good & bad when it comes to treatment for Any Disorder. And we All Need to Know what to watch for!

As far as I am concerned it will take 100 Yrs or more for any 'Truths' to be established about Any Treatment. My meds are 100 yrs Old! Yet (sorry for repeating myself) 7 yrs ago?? a New side effect Was Discovered. Mood Swings! And Yes, I had been having them for ever, just didn't Know or even Suspect it was caused by my meds. So, my book, never discredit any one's Info /Experience! Good or Bad!

HUGS to All! Thank You, again, Dana for doing the 'homework'.

Love Candi

Thanks for your Reply!

Report This| Share this:Vagus Nerve StimulatorThank You Dana. Yes, Dennis Said his was implanted in 2000 & he even gave 2012 Stats. So, he Has done his Homework as well as shared his experience. I agree: There is good & bad when it comes to treatment for Any Disorder. And we All Need to Know what to watch for!

As far as I am concerned it will take 100 Yrs or more for any 'Truths' to be established about Any Treatment. My meds are 100 yrs Old! Yet (sorry for repeating myself) 7 yrs ago?? a New side effect Was Discovered. Mood Swings! And Yes, I had been having them for ever, just didn't Know or even Suspect it was caused by my meds. So, my book, never discredit any one's Info /Experience! Good or Bad!

As ya'll know what I thought were drop attacks actually were 30 seconds of cardiac arrest during the stimulation cycles. If you or a loved one with the device develops a sudden increase or new onset of atonic seizures get yourself to the doctor ASAP and asked to have the vns turned off before it kills you.

Examples from the FDA's adverse database_____________________________________________

Report This| Share this:Vagus Nerve StimulatorAs ya'll know what I thought were drop attacks actually were 30 seconds of cardiac arrest during the stimulation cycles. If you or a loved one with the device develops a sudden increase or new onset of atonic seizures get yourself to the doctor ASAP and asked to have the vns turned off before it kills you.

Examples from the FDA's adverse database_____________________________________________

The symptoms of vagus nerve damage vary from the area of damage to the severity of the damage that has taken place. Below mentioned are the most well known symptoms of vagus nerve damage.

Vocal Changes: As mentioned earlier, the vagus nerve meanders all the way from the brain stem to the tongue, neck, heart etc. Therefore, damage to this nerve can also result in difficulty in speaking as the movement of tongue becomes troublesome. The voice of the person may also become hoarse.

Gag Reflex: As mentioned earlier, the vagus nerve is responsible for governing the responses of the reflex range. A damage may result in loss of reflex or gag reflex which can result in choking!

Dysphagia: Dysphagia is a condition wherein a person experiences difficulty while swallowing! As the vagus nerve controls the movement of the tongue as well, its damage can also lead to dysphagia.

Digestive Problems: Another symptom of vagus nerve damage would be suffering from digestive problems like constipation, indigestion, etc.

Deafness: A branch of the vagus nerve also passes through the ear, a damage to which may result in hearing loss resulting to deafness!

Cardiovascular Problems: As the vagus nerve also extends to the heart as well as the cardiovascular regions, the damage may result in symptoms like irregular heartbeat and other cardiovascular diseases like arrhythmia. If this is the case then the patient may suffer from symptoms like chest pain, breathing problems and also dizziness.

Urinary Incontinence: Urinary incontinence is another symptom which can result from a vagus nerve damage as this nerve also innervates the bladder muscles.

The symptoms of vagus nerve damage vary from the area of damage to the severity of the damage that has taken place. Below mentioned are the most well known symptoms of vagus nerve damage.

Vocal Changes: As mentioned earlier, the vagus nerve meanders all the way from the brain stem to the tongue, neck, heart etc. Therefore, damage to this nerve can also result in difficulty in speaking as the movement of tongue becomes troublesome. The voice of the person may also become hoarse.

Gag Reflex: As mentioned earlier, the vagus nerve is responsible for governing the responses of the reflex range. A damage may result in loss of reflex or gag reflex which can result in choking!

Dysphagia: Dysphagia is a condition wherein a person experiences difficulty while swallowing! As the vagus nerve controls the movement of the tongue as well, its damage can also lead to dysphagia.

Digestive Problems: Another symptom of vagus nerve damage would be suffering from digestive problems like constipation, indigestion, etc.

Deafness: A branch of the vagus nerve also passes through the ear, a damage to which may result in hearing loss resulting to deafness!

Cardiovascular Problems: As the vagus nerve also extends to the heart as well as the cardiovascular regions, the damage may result in symptoms like irregular heartbeat and other cardiovascular diseases like arrhythmia. If this is the case then the patient may suffer from symptoms like chest pain, breathing problems and also dizziness.

Urinary Incontinence: Urinary incontinence is another symptom which can result from a vagus nerve damage as this nerve also innervates the bladder muscles.

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